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Smoking Treatment in HIV Clinical Care Settings

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Gary Humfleet, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00297453
First received: February 24, 2006
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

The study is designed to evaluate and compare the efficacy and cost effectiveness of 3 smoking cessation treatments with HIV-positive cigarette smokers. The treatments include face-to-face individual counseling, a computer-Internet-based self-help treatment and a self-help manual treatment.


Condition Intervention Phase
Nicotine Dependence
 Behavioral: Internet-based smoking treatment
Behavioral: Individual Counseling
Behavioral: self-help
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Smoking
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 7 day point prevalence biochemically verified abstinence rates [ Time Frame: 3, 6, 9, and 12 months following treatment initiation ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: January 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet
Individual counseling + nicotine replacement. 6 sessions across a 3 month period.
 Behavioral: Internet-based smoking treatment
All participants have access to an Internet-based self-help intervention that includes social support through message boards. All participants have access to 10 weeks of nicotine replacement treatment.
Experimental: Counseling
Individual counseling plus nicotine replacement treatment.
 Behavioral: Individual Counseling
Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.
Active Comparator: Self-Help
Self-help Manual plus nicotine replacment treatment.
 Behavioral: self-help
Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV positive
  • 18 years or older
  • smoking "most days" during the past month
  • must be able to read English

Exclusion Criteria:

  • any contraindications for over-the-counter nicotine replacement treatment
  • active psychotic symptoms
  • severe cognitive deficits/dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297453

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Gary Humfleet, Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: Gary Humfleet, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00297453     History of Changes
Other Study ID Numbers: NIDA 09253-7, P50DA009253
Study First Received: February 24, 2006
Last Updated: June 25, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013